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| 申请号 | 产品号 | 商品名 | 活性成分 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 申请机构 | 批准时间 | 参比制剂 | 标准制剂 | 市场状态 | TE |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (NDA) 200656 | 004 | KABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 氨基酸;氯化钙;葡萄糖;硫酸镁;氯化钾;醋酸钠;甘油磷酸钠;豆油 | EMULSION;INTRAVENOUS | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML) | FRESENIUS KABI USA | 2014-08-25 | Yes | No | RX | |
| (NDA) 019714 | 004 | AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;氯化钾;磷酸氢二钾;氯化钠 | INJECTABLE;INJECTION | 4.25%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | ABBOTT | 1988-09-12 | No | No | DISCN | |
| (NDA) 019683 | 003 | AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;氯化钾;磷酸氢二钾;氯化钠 | INJECTABLE;INJECTION | 4.25%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | HOSPIRA INC | 1988-11-07 | No | No | DISCN | |
| (NDA) 019714 | 003 | AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;氯化钾;磷酸氢二钾;氯化钠 | INJECTABLE;INJECTION | 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | ABBOTT | 1988-09-12 | No | No | DISCN | |
| (NDA) 019683 | 004 | AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;氯化钾;磷酸氢二钾;氯化钠 | INJECTABLE;INJECTION | 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | HOSPIRA INC | 1988-11-07 | No | No | DISCN | |
| (ANDA) 209088 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | AM REGENT | 2017-07-27 | No | No | RX | AP |
| (ANDA) 217524 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | AMNEAL | 2024-07-08 | No | No | RX | AP |
| (ANDA) 219342 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | EXTROVIS | 2024-11-27 | No | No | RX | AP |
| (ANDA) 203477 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | INTL MEDICATION SYS | 2018-05-09 | No | No | RX | AP |
| (NDA) 019683 | 002 | AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;氯化钾;磷酸氢二钾;氯化钠 | INJECTABLE;INJECTION | 4.25%;36.8MG/100ML;20GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | HOSPIRA INC | 1988-11-07 | No | No | DISCN | |
| (NDA) 019714 | 002 | AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;氯化钾;磷酸氢二钾;氯化钠 | INJECTABLE;INJECTION | 4.25%;36.8MG/100ML;20GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | ABBOTT | 1988-09-12 | No | No | DISCN | |
| (NDA) 019683 | 001 | AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;氯化钾;磷酸氢二钾;氯化钠 | INJECTABLE;INJECTION | 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | HOSPIRA INC | 1988-11-07 | No | No | DISCN | |
| (NDA) 200656 | 005 | KABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 氨基酸;氯化钙;葡萄糖;硫酸镁;氯化钾;醋酸钠;甘油磷酸钠;豆油 | EMULSION;INTRAVENOUS | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML) | FRESENIUS KABI USA | 2014-08-25 | Yes | No | RX | |
| (NDA) 200656 | 006 | KABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 氨基酸;氯化钙;葡萄糖;硫酸镁;氯化钾;醋酸钠;甘油磷酸钠;豆油 | EMULSION;INTRAVENOUS | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML) | FRESENIUS KABI USA | 2014-08-25 | Yes | No | RX | |
| (ANDA) 218133 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | SOMERSET | 2024-12-17 | No | No | RX | AP |
| (NDA) 200656 | 001 | PERIKABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 氨基酸;氯化钙;葡萄糖;硫酸镁;氯化钾;醋酸钠;甘油磷酸钠;豆油 | EMULSION;INTRAVENOUS | 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML) | FRESENIUS KABI USA | 2014-08-25 | Yes | No | RX | |
| (NDA) 200656 | 002 | PERIKABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 氨基酸;氯化钙;葡萄糖;硫酸镁;氯化钾;醋酸钠;甘油磷酸钠;豆油 | EMULSION;INTRAVENOUS | 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML) | FRESENIUS KABI USA | 2014-08-25 | Yes | No | RX | |
| (NDA) 018725 | 001 | ACETATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE | 氯化钙;氯化钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 20MG/100ML;30MG/100ML;380MG/100ML;600MG/100ML | B BRAUN | 1982-11-29 | No | No | DISCN | |
| (NDA) 019714 | 001 | AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;氯化钾;磷酸氢二钾;氯化钠 | INJECTABLE;INJECTION | 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | ABBOTT | 1988-09-12 | No | No | DISCN | |
| (ANDA) 211553 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | MEDEFIL INC | 2019-05-01 | No | No | RX | AP |
